Vistakon Investigational Contact Lenses Worn for Daily Wear

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00717249
• Collaborator: (none)
• Enrollment: 529
• Locations: 20
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 26.5
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

This study compares the performance of an investigational contact lens to a currently marketed lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: galyifilcon A control lens; Device: galyfilcon A with a silver additive	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 529 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Lens galyfilcon A contact lens with a silver additive	Device: galyfilcon A with a silver additive; Investigational daily wear contact lens
Active Comparator: Control Lens galyfilcon A control contact lens	Device: galyifilcon A control lens; Marketed daily wear contact lens; Other Names: ACUVUE Advance with Hydraclear

Outcome Measures

Primary Outcome Measures

1. Slit Lamp Findings [6 months]

   Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.

2. Subject Reported Symptoms [6 months]

   Subjects were asked "Have you experienced any symptoms or problems since your last visit?" at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, "Dryness", "Other", "Cloudy/ Blurry / Hazy", "Irritation / Discomfort". The percentage of each response across all visits was reported.

3. Visual Acuity [6 months]

   Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.

4. Average Contact Lens Wear Time [6 Months]

   The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. The subject must be at least 18 years of age.

2. Both males and females may be enrolled.

3. The subject must read, understand, and sign for themselves the STATEMENT OF INFORMED CONSENT and be provided with a copy of the form.

4. The subject is able and willing to wear soft contact lenses on a daily basis for a six month duration.

Exclusion Criteria:

1. The subject must be free of Grade 2 or greater slit lamp findings (edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, and other ocular abnormality), which would contraindicate contact lens wear.

2. Any active ocular (i.e. corneal infiltrates, conjunctiva, lids, and intraocular) infection or inflammation of an allergic, bacterial, or viral etiology.

3. Entropion, ectropion, chalazia, recurrent styes, glaucoma or glaucoma suspect, history of recurrent corneal erosions and aphakia.

4. The following medications are prohibited (at lease one week prior to enrollment): oral retinoid isoretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. antihistamines (e.g. Seldane, Chlor-Trimeton, and Benadryl), and ophthalmic antihistamic Beta-adrenergic blockers (e.g. Propranolol, Timolol, and Practolol), systemic steroids, and and prescribed or OTC ocular medication. Any prescription or PTC medications or preparations containing silver.

5. Moderate or above corneal distortion by keratometry.

6. Known allergy to silver, silver ions, or silver containing compounds.

7. Abnormal discoloration of the cornea and/or conjunctiva.

8. Routine exposure to silver, silver ions, or silver containing compounds.

9. The subject must be free of systemic diseases which may interfere with contact lens wear: diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases (e.g. AIDS)

10. Free of systemic and infectious diseases: hepatitis and tuberculosis.

11. Subjects must be HIV negative.

12. The subject must not be currently be pregnant or lactating (Subject becoming pregnant during the study will be discontinued).

13. The subject's eyes must be best corrected to a visual acuity of 20/30 or better in each eye.

14. The subject must not have more than 1.00D of refractive astigmatism in either eye.

15. The subject's distance spherical contact lens prescription must be between -1.00D and -6.00D.

16. The subject must not be monovision corrected.

17. The subject must have no history of solution reaction to Opti-free RepleniSH MPDS-No Rub Solution.

18. The subject must not have any previous history or signs of a contact lens related corneal inflammatory event (i.e. past peripheral ulcers or round peripheral scars)

19. The subject must not have participated in a device or pharmaceutical clinical trial within 30 days prior to study enrollment.

20. The subject must not have had an eye injury within 8 weeks prior to study enrollment.

21. The subject must not have had previous eye surgery.

22. The subject must be successfully trial fitted with the study contact lenses.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cole, Cole, and Krohn	Fresno	California	United States	93704
2	Dr. James R. Dugue Family Optometrist	Mission Viejo	California	United States	92691
3	Fukai and Associates	Louisville	Colorado	United States	80027
4	Baymeadows Vision Center	Jacksonville	Florida	United States	32256
5	Eyecare Associates	Bloomington	Illinois	United States	61701
6	Advantage Eyecare Associates, LLC	Neodesha	Kansas	United States	66757
7	InSight Eyecare	Warrensburg	Missouri	United States	64093
8	Spectrum Eyecare	Jamestown	New York	United States	14750
9	Drs. Quinn, Quinn and Associates	Athens	Ohio	United States	45701
10	Dr. Michael H. Greenburg, Inc.	Chagrin Falls	Ohio	United States	44023
11	Central Ohio Eyecare	Columbus	Ohio	United States	43202
12	James W. Kershaw OD, Inc.	North Olmsted	Ohio	United States	44070
13	West Hills Vision Center	Moon Township	Pennsylvania	United States	15108
14	Nittany Eye Associates	State College	Pennsylvania	United States	16801
15	Research Across America	Wyomissing	Pennsylvania	United States	19610
16	Dr. David W. Ferris and Associates	Warwick	Rhode Island	United States	02886
17	Premier Vision	Amarillo	Texas	United States	79119
18	William J. Bogus OD	Salt Lake City	Utah	United States	84106
19	The Eye Speciliasts, Ltd	Virginia Beach	Virginia	United States	23455
20	Snowy Range Vision Center	Laramie	Wyoming	United States	82070

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00717249
• Other Study ID Numbers: CR-1513
• First Posted: Jul 17, 2008
• Last Update Posted: May 26, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	A total of 529 subjects were enrolled in this study. Of those enrolled subjects, 33 did not meet the eligibility criteria and 496 were randomized to either the test or control lens using a 2:1 allocation. Of those randomized subjects 491 were successfully dispensed. Of the dispensed subjects 454 subjects completed the study.

Arm/Group Title	Galyfilcon A w/ Silver	Galyfilcon A
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.	Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.
Period Title: Overall Study
STARTED	326	165
COMPLETED	304	150
NOT COMPLETED	22	15

Baseline Characteristics

Arm/Group Title	Galyfilcon A w/ Silver	Galyfilcon A	Total
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.	Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.	Total of all reporting groups
Overall Participants	326	165	491
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	31.9	29.8	30.9
Sex: Female, Male (Count of Participants)
Female	226 69.3%	98 59.4%	324 66%
Male	100 30.7%	67 40.6%	167 34%
Race/Ethnicity, Customized (participants) [Number]
Asian	5 1.5%	4 2.4%	9 1.8%
White	304 93.3%	147 89.1%	451 91.9%
African American	5 1.5%	3 1.8%	8 1.6%
Native American	0 0%	1 0.6%	1 0.2%
Asian - Indian	2 0.6%	0 0%	2 0.4%
Hispanic	8 2.5%	9 5.5%	17 3.5%
Other	2 0.6%	1 0.6%	3 0.6%
Region of Enrollment (participants) [Number]
United States	326 100%	165 100%	491 100%

Outcome Measures

1. Primary Outcome

Title	Slit Lamp Findings
Description	Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Galyfilcon A w/ Silver	Galyfilcon A
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.	Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
Measure Participants	304	150
Measure Subject Eyes	608	300
Number [Number of Subject Eyes]	7	2

2. Primary Outcome

Title	Subject Reported Symptoms
Description	Subjects were asked "Have you experienced any symptoms or problems since your last visit?" at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, "Dryness", "Other", "Cloudy/ Blurry / Hazy", "Irritation / Discomfort". The percentage of each response across all visits was reported.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Galyfilcon A w/ Silver	Galyfilcon A
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.	Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
Measure Participants	304	150
Measure Number of Observations	2548	1260
Dryness	9.9	6.3
Other	4.9	4.0
Cloudy/ Blurry / Hazy	2.8	2.5
Irritation / Discomfort	2.8	2.3

3. Primary Outcome

Title	Visual Acuity
Description	Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Galyfilcon A w/ Silver	Galyfilcon A
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.	Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
Measure Participants	304	150
Mean (Standard Deviation) [LogMAR]	0.004 (0.0891)	-0.009 (0.0866)

4. Primary Outcome

Title	Average Contact Lens Wear Time
Description	The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Galyfilcon A w/ Silver	Galyfilcon A
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.	Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
Measure Participants	304	150
Mean (Full Range) [time in hours]	14.0	14.0

Adverse Events

Time Frame	Throughout the duration of the study. Approximately 6 months.
Arm/Group Title	Galyfilcon A w/ Silver		Galyfilcon A
Arm/Group Description	Subjects that were randomized to receive the galyfilcon A contact lens with a silver additive during the entire course of the study.		Subjects that were randomized to receive the galyfilcon A contact lens during the entire course of the study.
All Cause Mortality
	Galyfilcon A w/ Silver		Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Galyfilcon A w/ Silver		Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/326 (0%)		1/165 (0.6%)
Eye disorders
Iritis	0/326 (0%)	0	1/165 (0.6%)	1
Other (Not Including Serious) Adverse Events
	Galyfilcon A w/ Silver		Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/326 (0%)		0/165 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.